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Best Practices and Pitfalls in Commercializing IVD-Applicable Biomarkers

Piia von Lode; Valérie Daussin; Susan Raths; Simona Padurariu

Before biomarker discoveries can be commercially utilized in clinical laboratories, many studies and surveys need to be completed and many questions answered. Is there a market need? Is there enough scientific and clinical evidence to convince the end users? Is the biomarker patentable? Is the translation into a practical product feasible?

Although commercial product development is not the focus of academic research, the route to reach the patients will almost always require a professional commercialization process. Understanding industry and end-user requirements is essential for the successful commercialization of new biomarker assays.

The current handbook collects some of the best practices and pitfalls encountered at different phases of biomarker discovery, development, patent protection and technology transfer at universities, hospitals and research organizations. The focus is on in vitro diagnostics (IVD)-applicable biomarkers, i.e. markers intended to provide information on the health status of a person.

The input for the collection has been sought from true-life practices: 

  • practices found in literature or taught by experts in the field; 
  • opinions and expertise of different stakeholders (end users, companies, technology transfer professionals, researchers, financiers); 
  • recommendations, regulation and laws
  • as well as practices learned the hard way, i.e. repeatedly failing somewhere in the process and later adapting the process for increased success.

The main target group of the handbook comprises professionals working in Technology Transfer Offices (TTOs). The presented practices are yet not intended to be interpreted as strict rules but rather as a source of inspiration. 
Optimal ways to proceed with patenting and commercialization significantly vary between cases and circumstances.

The handbook has been prepared within the EU-project Biomarker Commercialization (BIC) comprising 9 partners in the Baltic Sea Region (BSR) united with the same challenges, as well as the common objective of more efficiently bringing new and better IVD-applicable biomarkers from discovery into clinical use. The project's budget is EUR 2.55 million and is co-financed by the European Regional Development Fund through the Interreg Baltic Sea Region Programme with EUR 1.96 million.
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